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A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This study aims to investigate whether a class of diabetes medications called GLP-1 receptor agonists (GLP-1RA), specifically semaglutide or polyethylene glycol loxenatide, can improve heart-related nerve damage in people with type 2 diabetes. This heart-related nerve damage is known as diabetic cardiac autonomic neuropathy (DCAN), which can cause problems such as fast resting heart rate, low blood pressure upon standing, and in severe cases, heart attack or sudden death. In this study, 60 adults with type 2 diabetes (ages 18-80) will be randomly divided into two groups. One group will receive standard diabetes care only, while the other group will receive standard care plus a once-weekly injection of either semaglutide or polyethylene glycol loxenatide for 6 months. Participants will undergo tests before and after the treatment period, including blood tests and non-invasive heart function tests (24-hour heart rate variability monitoring and cardiac autonomic reflex tests). The main goal is to see whether GLP-1RA treatment improves heart rate variability, a key sign of heart nerve function. The study also looks at changes in body weight, blood sugar control, and insulin resistance. This research may help determine whether GLP-1RA medications can protect against or improve diabetic heart nerve damage, beyond their known benefits for blood sugar control.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients aged 18-70 years

• Patients with type 2 diabetes mellitus (T2DM) who meet the diagnostic guidelines

• Patient has signed the relevant informed consent form

• Being overweight or obese (BMI ≥ 24 kg/m²)

Locations
Other Locations
China
the First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
jianbo Li
ljbzjlx18@aliyun.com
13115008178
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2028-08-30
Participants
Target number of participants: 60
Treatments
No_intervention: Control Group
Participants receive standard diabetes care (routine glucose-lowering treatment) without GLP-1 receptor agonist (GLP-1RA) intervention.
Experimental: GLP-1 Receptor Agonist (GLP-1RA) Group
Participants receive standard diabetes care plus a once-weekly subcutaneous injection of a GLP-1 receptor agonist (either semaglutide or polyethylene glycol loxenatide) for 6 months. Semaglutide is administered at 0.5 mg once weekly; polyethylene glycol loxenatide is administered at 0.2 mg once weekly. Both are used within approved labeling for type 2 diabetes.
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov